The Effects of Intravenous Fosaprepitant and Ondansetron for the Prevention of Postoperative Nausea and Vomiting in Thoracicsurgery Patients: A Single-center, Randomized, Double-Blinded Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 234
- 主要终点
- Incidence of PONV within 24 hours
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy, safety and feasibility of intravenous Fosaprepitant and Ondansetron for the prevention of postoperative nausea and vomiting in thoracicsurgery patients. Participants will be randomized in a 1:1 ratio to the Fosaprepitant and Ondansetron group.The groups were analyzed and compared for frequency of vomiting in 24 h after surgery. In addition, we will further compare the occurrence of postoperative pulmonary complications, length of hospital stay, nutrition and quality of life after surgery in patients treated with different antiemetic prophylaxis.
详细描述
Postoperative nausea and vomiting (PONV) is a common postoperative complication of general anesthesia. The antiemetic 5-serotonin 3 (5-HT 3) receptor antagonist is widely used in postoperative anti-emesis,However, more clinical studies are needed to confirm whether neurokinin-1 (NK-1) receptor antagonists have better effects on PONV than 5-HT 3 receptor antagonists.We aimed to evaluate the effects of NK-1 receptor antagonists and 5-HT 3 receptor antagonists on PONV through a randomized controlled study. To this end, we took patients undergoing thoracic surgery as the research object, they received an antiemetic prophylaxis with ondansetron or fosaprepitant, and the frequency of postoperative nausea and vomiting the of the two antiemetic prophylaxis regimens were analyzed, and the occurrence of pulmonary complications, length of hospital stay, the nutrition and quality of life after surgery administration were also compared. Through this clinical trial, we hope to obtain a better antiemetic prophylaxis regimen and provide clear information for patients and physicians to guide clinical decisions that enhance treatment efficacy and reduce the occurrence of side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 70 years
- •physical status classified by the American Society of Anesthesiologists (ASA) scale as I to III
- •Apfel score ≥ 2
- •undergoing thoracoscopic pneumonectomy
排除标准
- •Preoperative disorders of consciousness
- •body mass index (BMI) > 35 kg/m2
- •occurrence of episodes of nausea or vomiting within 24 h prior to surgery、motion sickness,、previous PONV、people who smoke、people with alcoholism、use of corticosteroids, psychoactive or antiemetic drugs,、hypersensitivity to the study medications
- •serious kidney, liver, lung, heart, brain or bone marrow disease
- •conversion from thoracoscopic pneumonectomy to conventional pneumonectomy
- •participation in another clinical study.
研究组 & 干预措施
Fosaprepitant
Participants undergoing thoracoscopic pneumonectomy will receive 150 mg of fosaprepitant and 100 ml of normal saline, administer intravenously after the induction of general anesthesia.
干预措施: Fosaprepitant 150 mg (Drug)
Ondansetron
Participants undergoing thoracoscopic pneumonectomy received 8 mg of ondansetron and 100 ml of normal saline, administer intravenously after the induction of general anesthesia.
干预措施: Ondansetron 8mg (Drug)
结局指标
主要结局
Incidence of PONV within 24 hours
时间窗: Day 1
The groups will be analyzed and compared for frequency of nausea and vomiting in 24 h after surgery
次要结局
- Incidence of PONV within 48 hours(Day 2)
- the length of hospital stay(From date of admission until the date of discharge, assessed up to 7 days.)
- postoperative pulmonary complications(Day 3)
- Postoperative pain score(Day 3)
- The dosage of opioids used after surgery(Day 3)
- occurrence of Drug-related adverse effects(Day 3)